The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Chemotherapy: Paclitaxel 175mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for NSCLC; Pemetrexed 500mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for non-squamous NSCLC; intravenous infusion every 3 weeks, for up to four cycles. Sugemalimab: 1200 mg by intravenous infusion every 3 weeks, for up to 2 years.
Hunan Cancer Hospital
Changsha, China
RECRUITINGORR
Objective response rate
Time frame: From the initiation of the first dose to 3 years
PFS
Progression-free survival
Time frame: From the initiation of the first dose to 3 years
OS
Overall survival
Time frame: From the initiation of the first dose to 3 years
iORR
Objective response rate after induction therapy
Time frame: From the initiation of the first dose to 3 years
AEs
Adverse events
Time frame: From the initiation of the first dose to 90 days after the last dose
Measurement of Quality of Life with EORTC QLQ-C30 questionnaire
EORTC QLQ-C30 questionnaire minimum value: not at all (1); maximum: very much (4); higher scores means a worse outcome
Time frame: From the initiation of the first dose to 3 years
Measurement of Quality of Life with EORTC QLQ-LC13 questionnaire
EORTC QLQ-LC13 questionnaire minimum value: not at all (1); maximum: very much (4); higher scores means a worse outcome
Time frame: From the initiation of the first dose to 3 years
Measurement of Quality of Life with EORTC EQ-5D-5L VAS questionnaire
The EQ-5D-5L VAS records the respondent's self-rated health on a 10 centimeter (cm) vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine"
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Time frame: From the initiation of the first dose to 3 years